Constrained knee arthroplasty

Abstract

To provide a constrained prosthetic knee.SOLUTION: In a prosthesis assembly, a hinge post can extend through a tibial bearing component and be at least partially received in a recess of a tibial tray. A femoral component can contact an articular surface of the tibial bearing component. A shackle can be coupled to the hinge post and configured to be inserted between a medial condyle and a lateral condyle of the femoral component. Walls can be positioned between the femoral component and the shackle. A hinge axle can be configured to secure the femoral component to the shackle. A bump stop can be removably attached to the femoral component and configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] Claiming priority This application claims the benefit of U.S. Provisional Patent Application No. 63 / 434,563, filed December 22, 2022, and U.S. Provisional Patent Application No. 18 / 526,693, filed December 1, 2023, the benefit of which is hereby claimed and incorporated by reference in its entirety.

[0002] The present subject matter relates generally to orthopedic prostheses. More specifically, the present disclosure relates to orthopedic prostheses used in constrained knee arthroplasty. [Background technology]

[0003] Orthopedic procedures and prostheses are commonly used to repair or replace damaged bones and tissues in the human body. Generally, the knee is formed by a pair of condyles on the distal portion of the femur, the inferior surface of which bears against a correspondingly shaped proximal surface plateau of the tibia. The femur and tibia are connected by ligaments such as the posterior cruciate ligament, the lateral collateral ligament, the medial collateral ligament, and the anterior cruciate ligament. These ligaments provide stability to the knee joint.

[0004] A knee prosthesis can be considered either constrained or unconstrained. A constrained knee prosthesis can include femoral and tibial prostheses that are mechanically linked or constrained to one another to limit relative movement between the femoral and tibial prostheses. Common mechanisms for such mechanical linkages can include hinges, bands, or other linkage structures. An unconstrained knee prosthesis includes femoral and tibial prostheses that are not mechanically linked. An unconstrained knee utilizes the patient's remaining ligaments and other soft tissues to provide stability to the joint. A constrained knee prosthesis is particularly applicable in cases where a patient experiences ligament loss and / or the remaining ligaments do not provide adequate support and stability to the knee. Summary of the Invention [Problem to be solved by the invention]

[0005] The present disclosure relates generally to improved constrained knee prostheses, particularly those utilizing hinge posts. Some constrained knee prostheses with hinge posts utilize a design in which the femoral component (and hinge post) is free to move proximally / distally relative to the tibial baseplate and tibial bearing component. Such an arrangement can allow for distraction of the knee joint. However, the inventors have found that a certain demographic of patients receiving constrained knee prostheses with hinge posts may not have enough soft tissue within the knee joint to prevent the femoral component from distracting from the tibial baseplate and tibial bearing and subsequently dislocating. Dislocation can result in pain and other complications for the patient. [Means for solving the problem]

[0006] Design constraints for improved prostheses call for components with increased width to improve the strength of such components. Additionally, the inventors of the present application have discovered that with the present knee prosthesis, adjustments that may alter the rotation of the femoral component as it relates to the tibial baseplate are minimal.

[0007] Various embodiments are shown by way of example in the accompanying drawing figures. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present subject matter. [Brief description of the drawings]

[0008] [Figure 1] FIG. 1 illustrates a knee joint structure that provides a suitable environment in which a constrained prosthesis assembly according to one embodiment of the present application can be utilized. [Diagram 2] FIG. 2 illustrates a knee joint structure that provides a suitable environment in which a constrained prosthesis assembly according to one embodiment of the present application can be utilized. [Diagram 3] FIG. 3 is a perspective view of a constrained knee prosthesis assembly according to one embodiment of the present application. [Figure 4] FIG. 4 is an exploded view of the constrained knee prosthesis assembly of FIG. [Diagram 5] FIG. 5 is a cross-sectional view of an embodiment of a constrained knee prosthesis in accordance with one embodiment of the present application. [Figure 6] FIG. 6 is a perspective view of an embodiment of a femoral component according to an embodiment of the present application. [Figure 7] FIG. 7 is a perspective view of a portion of a constrained knee prosthesis according to one embodiment of the present application. [Figure 8] FIG. 8 is an exploded view of a portion of the constrained knee prosthesis of FIG. 7 according to one embodiment of the present application. [Figure 9] FIG. 9 is a cross-sectional view of a portion of a constrained knee prosthesis according to one embodiment of the present application. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The present application relates to a constrained knee prosthesis. The prosthesis may include a shackle having an increased width to improve the strength of the shackle. The femoral component may include a frusto-conical profile to accommodate the shackle having the increased width and fit within the same overall prosthesis envelope. The prosthesis may also include a wall that at least partially surrounds the shackle and is configured to engage with a frusto-conical profile on the femoral component, which may also include a frusto-conical profile that is complementary to the frusto-conical profile on the femoral component.

[0010] The prosthesis may also include a bump stop that may be removably attached to the femoral component such that when the knee is in extension, the bump stop contacts the shackle to prevent further rotation of the femoral component relative to the tibial baseplate. The prosthesis may be configured to make the bump stop serviceable. Thus, the bump stop may be removed, e.g., adjusted to quickly change the rotation of the femoral component relative to the tibial baseplate without removing the bump stop, or replaced without removing the prosthesis from the knee. For example, the prosthesis may be configured to remove, adjust, or replace the bump stop when the knee is in flexion.

[0011] To better understand knee replacement surgery, it may be useful to understand the relationship between bone cuts and bones that can be made to orient various provisional and permanent prosthetic components within the knee joint. Figures 1 and 2 illustrate some features and orientations of the knee joint structure. In Figure 1, a front view of a leg 102 including a femur 104 and a tibia 106 illustrates various leg axes. The femur 104 has an anatomical axis 108 that generally coincides with its intramedullary canal. The femur 104 also has a mechanical axis 110 or load axis that extends from the center of the femoral head 112 to the center of the knee joint 114. The angle 116 extending between these two axes varies between patient populations, but is generally between 5 degrees and 7 degrees. Like the femur 104, the tibia 106 also has an anatomical axis that generally coincides with its intramedullary canal. The mechanical axis 118 of the tibia 106 extends from the center of the knee joint 114 to the center of the talocrural portion 120 and is generally collinear with its anatomical axis.

[0012] A joint line 122, about which the knee joint 114 flexes, is approximately parallel to a line through the medial and lateral femoral condyles 124 and to the tibial plateau 126. Although illustrated as being at a right angle in Figure 1, the joint line 122 can extend at a varus or valgus angle relative to the mechanical axes 110 and 118 of the femur 104 and tibia 106, respectively. Typically, during partial or total knee replacement, a portion of the distal end of the femur 104 or the proximal end of the tibia 106 is resected parallel or nearly parallel to the joint line 122 and therefore perpendicular to the mechanical axes 110 and 118, as indicated at 128 and 130, respectively.

[0013] A typical knee can move between an extension state, in which the longitudinal axes of the femur 104 and the tibia 106 are essentially parallel, and a flexion state, in which the longitudinal axes of the femur 104 and the tibia 106 form an angle of approximately 140 degrees relative to one another. In embodiments, the extension state can be limited to + / - 10 degrees, and the flexion state can be much less than 140 degrees. For example, the flexion state can include limits in which the longitudinal axes of the femur 104 and the tibia 106 form an angle of approximately 90 degrees to 140 degrees relative to one another.

[0014] 2 illustrates a closer view of the knee joint 114 and its coordinate system, where the medial / lateral axis 202 corresponds approximately to the joint line 122 (see FIG. 1), the proximal / distal axis 204 corresponds approximately to the mechanical axis 110 (see FIG. 1), the mechanical axis 118 (see FIG. 1), and the anterior / posterior axis 206 is approximately perpendicular to the other two axes. Arrows can be depicted along each of these axes, representing the medial / lateral 208, anterior / posterior 210, and proximal / distal 212 positions of the inserted prosthetic components. Rotation about each of these axes can also be depicted by arrows. Rotation about the proximal / distal axis 204 can correspond to the external rotation of the anatomical femoral component, while rotation about the anterior / posterior axis 206 and the medial / lateral axis 202 can correspond to the extension plane slope and varus / valgus angle of the component, respectively. Depending on the location of the proximal tibial cut 130 (see FIG. 1 ) made, the varus / valgus angle 214, extension plane angle 216, external rotation 218, or joint extension gap can be affected. Also, the location of the distal femoral cut 128 (see FIG. 1 ) can affect the location of the joint line 122, the extension gap, varus / valgus angle 214, or extension plane angle 216.

[0015] The terms "proximal" and "distal" as used herein should be given their commonly understood anatomical interpretation. The term "proximal" generally means a direction toward the patient's torso, and the term "distal" generally means a direction opposite to proximal, i.e., away from the patient's torso. It should be understood that the terms "proximal" and "distal" should be interpreted as if the patient were standing with the knee joint extended. The intent is to distinguish the terms "proximal" and "distal" from the terms "anterior" and "posterior". The terms "anterior" and "posterior" as used herein should be given their commonly understood anatomical interpretation. Thus, "posterior" means the posterior of the patient, e.g., behind the knee. And, "anterior" means the front of the patient, e.g., in front of the knee. Thus, "posterior" means the opposite direction of "anterior". And, the term "lateral" means the opposite direction of "medial". The term "medial / lateral" means from medial to lateral or lateral to medial. The term "proximal / distal" means proximal to distal or distal to proximal. The term "anterior / posterior" means anterior to posterior or posterior to anterior.

[0016] As used herein, the "periphery" of a tibial baseplate means any periphery as seen, for example, in a top view generally in a transverse anatomical plane. Alternatively, the periphery of the tibial baseplate may be any periphery as seen, for example, in a bottom view generally in a transverse plane and looking at a distal surface adapted to contact the resected proximal surface of the tibia.

[0017] 3 illustrates a constrained knee prosthesis assembly 300. The prosthesis assembly 300 can include a tibial baseplate 302, a tibial bearing component 304 (sometimes referred to as a meniscal component, poly, articular component or bearing), a femoral component 306, and a hinge post 308.

[0018] The tibial bearing component 304 may be positioned atop the proximal surface 310 of the tibial baseplate 302. The tibial bearing component 304 may be formed of a polymeric material such as ultra-high molecular weight polyethylene ("UHMWPE"). The tibial bearing component 304 may be configured to articulate with the femoral component 306 through flexion and extension of the knee joint, as is known in the art. The prosthetic assembly 300 has the femoral component 306 and the tibial baseplate 302 mechanically linked to one another. This is accomplished by a hinge post 308 and other components further illustrated and discussed in FIG. 4. The hinge post 308 is coupled to the femoral component 306 and received within a recess 309 in the tibial bearing component 304 and a recess 322 in the tibial baseplate 302 (FIG. 4).

[0019] FIG. 4 shows an exploded view of the prosthesis assembly 300, tibial baseplate 302, tibial bearing component 304, femoral component 306, hinge post 308, and further illustrates the hinge axle 312, poly box 314, axle bushing 316, shackle 318, and bushing.

[0020] The hinge post 308 is coupled to the femoral component 306 via a shackle 318, an axle bushing 316, and a hinge axle 312. A distal portion of the shackle 318 is received within a recess 309 in the tibial bearing component 304, and a distal portion is threaded or otherwise coupled to the hinge post 308. The hinge post 308 extends distally through the recess 309 in the tibial bearing component 304 and is received within a recess 322 in the tibial baseplate 302. The recess 322 in the tibial baseplate 302 that receives the hinge post 308 may be formed at least in part by a keel 324 of the baseplate 302. The hinge post 308 may be movable, e.g., rotatable or extendable, relative to the tibial bearing component 304 or the tibial baseplate 302. The hinge post 308 may be rotatably coupled to the femoral component 306 via the hinge axis 312. Thus, a longitudinal axis LA defining a centerline of the hinge post 308 may define a rotation / articulation axis ARA for the knee joint since the femoral component 306 and the tibial baseplate 302 are mechanically linked.

[0021] When assembled, the shackle 318 can be placed between the opposing walls of the poly box 314. When assembled onto the hinge axle 312, the axle bushing 316 also resides within an opening on the proximal portion of the shackle 318. The shackle 318 and hinge post 308 can be formed of a suitable material, such as a titanium alloy, a cobalt-chromium alloy, while the axle bushing 316 and poly box 314 can be formed of a different material, such as a plastic, such as UHMWPE. The axle bushing 316 can act as a bearing between the shackle 318 and the hinge axle 312. The poly box 314 can act as a bearing between the femoral component 306 and the shackle 318.

[0022] The prosthesis assembly 300 of FIG. 4 illustrates a system 326 of components in which knee extension is not limited by capture elements or other features of the prosthesis assembly 300. Thus, the system 326 provides components configured for full extension when assembled. Thus, as previously discussed, the soft tissue of the knee is relied upon to limit extension between the femoral component 306 and the tibial baseplate 302 and tibial bearing component 304. The bushing 320 can be configured for insertion into at least the recess 322 of the tibial baseplate 302. The bushing 320 can also be inserted into or through the recess 309 (see FIG. 3) of the tibial bearing component 304 in some embodiments. The bushing 320 can be configured to receive at least a portion of the hinge post 308. The bushing 320 can act as a bearing between the hinge post 308 and the tibial baseplate 302. The hinge post 308 may be generally proximally / distally movable relative to the bushing 320 .

[0023] 5 is a cross-sectional view of an embodiment of a constrained knee prosthesis assembly, according to an embodiment of the present application, a prosthesis assembly 500. The prosthesis assembly 500 can include a tibial tray 502, a tibial bearing component 504, a femoral component 506, a hinge post 508, a shackle 518, and a hinge axis 512.

[0024] The tibial tray 502, e.g., the tibial baseplate 302 of FIGS. 3-4, can extend from a proximal surface 510, e.g., the proximal surface 310 of FIG. 3, to a distal surface. The proximal surface 510 and the distal surface can define a periphery therebetween. The periphery can extend between an anterior edge and a posterior edge of the tibial tray 502. The proximal surface 510 can include a recess 522, which can extend toward the distal surface. The recess 522, e.g., the recess 322 of FIG. 4, can be configured to at least partially accommodate the hinge post 508.

[0025] A tibial bearing component 504, such as the tibial bearing component 304 of FIGS. 3-4, is engageable with the tibial tray 502. For example, the tibial tray 502 can support the tibial bearing component 504 while the tibial bearing component 504 engages with the femoral component 506. In one embodiment, the tibial bearing component 504 can include an articular surface 505. The articular surface 505 can be configured to engage with the femoral component 506. More specifically, the articular surface 505 can be configured to engage with the medial and lateral condyles of the femoral component 506.

[0026] A femoral component 506 , such as the femoral component 306 of FIGS. 3-4 , can contact the articular surface 505 of the tibial bearing component 504 and can be configured to articulate with the tibial bearing component 504 .

[0027] A hinge post 508, such as the hinge post 308 of FIGS. 3-4, can extend through the tibial bearing component 504 and can be at least partially received within the recess 522 of the tibial tray 502. The hinge post 508 can include a portion within the recess 522 of the tibial tray 502 and a portion that extends outside the recess 522 of the tibial tray 502. The portion of the hinge post 508 that extends within the recess 522 can include threads that are complementary to the threads within the recess 522. The portion of the hinge post 508 that extends outside the recess 522 can be configured to extend through the femoral component 506 such that the femoral component 506 surrounds the hinge post 508 when the hinge post 508 is seated within the recess 522 of the tibial tray 502. The portion of the hinge post 508 that extends outside of the recess 522 may be received by a bushing that includes a threaded surface, any other attachment mechanism, or the like that may be complementary to the attachment mechanism on the shackle 518 .

[0028] The shackle 518, e.g., the shackle 318 of FIGS. 3 and 4, is configured to couple to the hinge post 508 and can have other components of the prosthesis assembly 500 attached thereto for attaching additional components to the prosthesis assembly 500. The shackle 518 can extend between a first end 530 and a second end 532. The first end 530 can be configured to attach, couple or mate to the hinge post 508. For example, the first end 530 can include a threaded surface that is complementary to a threaded surface of the portion of the hinge post 508 that extends outside of the recess 522. The second end 532 can be configured to receive the hinge axle 512 for attaching one or more components of the prosthesis assembly 500 to the shackle 518. For example, the second end 532 can include an opening configured to receive the hinge axle 512. The shackle 518 can be configured to be inserted into the intercondylar region 507 of the femoral component 506 .

[0029] The hinge axle 512, such as the hinge axle 312 of FIGS. 3 and 4, can be configured to secure, among other components, the femoral component 506 to the shackle 518 and through the shackle 518 to the hinge post 508. The hinge axle 512 can be an elongated member that extends a distance greater than a thickness of the femoral component 506 such that the hinge axle 512 can be used to hold components, including the femoral component 506, on the shackle 518. For example, the hinge axle 512 can attach the femoral component 506 and the wall 514 to the shackle 518 through an opening in the shackle 518 that is configured to receive the hinge axle 512. The prosthesis assembly 500 can also include one or more bushings, washers, or any other components that can be complementary to the interaction between the hinge axle 512 and the opening in the shackle 518.

[0030] Walls 514, such as poly box 314 of FIGS. 3-4, are discussed in further detail below with reference to FIGS.

[0031] The prosthesis assembly 500 may also include a bump stop 528 that may be removably attached to the femoral component 506. As shown in Figure 5, when the prosthesis assembly 500 is in extension, the bump stop 528 may contact the shackle 518 to prevent further rotation of the femoral component 506 relative to the tibial bearing component 504. The bump stop 528 is discussed in more detail below with reference to Figures 7-9.

[0032] 6 is a perspective view of an example femoral component, such as femoral component 506, according to an embodiment of the present invention. In the example, femoral component 506 can include an intercondylar region 507 extending between a medial condyle and a lateral condyle of the femoral component 506. The femoral component 506 can include an internal medial condyle wall 509 and an internal lateral condyle wall 511. The intercondylar region 507 can extend between the internal medial condyle wall 509 and the internal lateral condyle wall 511. The intercondylar region 507, the internal medial condyle wall 509 and the internal lateral condyle wall 511 can be configured to engage a shackle 518, more specifically, wall 514, during articulation of the prosthetic assembly 500.

[0033] The internal medial condyle wall 509 can include a frustoconical profile 513, and the internal lateral condyle wall 511 can include a frustoconical profile 515. In one embodiment, the frustoconical profile 513 can extend across the entire internal medial condyle wall 509. In another embodiment, the frustoconical profile 513 can extend across only a portion of the internal medial condyle wall 509. In one embodiment, the frustoconical profile 515 can extend across the entire internal lateral condyle wall 511. In another embodiment, the frustoconical profile 515 can extend across only a portion of the internal lateral condyle wall 511. The frustoconical profile 513 of the internal medial condyle wall 509 and the frustoconical profile 515 of the internal lateral condyle wall 511 can maximize the thickness of the internal medial condyle wall 509 and the internal lateral condyle wall 511, respectively, to minimize the space taken up by the internal medial condyle wall 509 and the internal lateral condyle wall 511 while maximizing the strength of the internal medial condyle wall 509 and the internal lateral condyle wall 511. Additionally, the frustoconical profile 513 and the frustoconical profile 515 can be configured to reduce stress concentrations in the internal medial condyle wall 509 and the internal lateral condyle wall 511, respectively.

[0034] 7 and 8 are discussed together below. FIG. 7 is a perspective view of a portion of a constrained knee prosthesis, such as a prosthesis assembly 500, according to one embodiment of the present application. FIG. 8 is an exploded view of the prosthesis assembly 500. The prosthesis assembly 500 can include two or more poly or serviceable walls (walls 514). The walls 514 can be configured to surround at least a portion of the shackle 518. In an embodiment, the shackle 518 can be an overmolded piece that is held in place over the shackle 518 by a hinge axle 512 that extends through an opening in the wall 514. In another embodiment, the wall 514 can fit over the shackle 518 such that the hinge axle 512 holds the wall 514 on the shackle 518. Here, the wall 514 can be attached to the shackle 518 via the hinge axle 512 and an opening in the second end 532 of the shackle 518.

[0035] As shown in Figures 3-4 above, the poly box 314 may be a one-piece design configured to partially surround the shackle 318. However, as shown in Figures 7 and 8, the wall 514 may also be a two-piece design configured to at least partially surround the shackle 518. Thus, the wall 514 may include a first wall 534 and a second wall 536. The two-piece design of the wall 514 may make the wall 514 easier to manufacture as it is less complex than the one-piece design of the poly box 314. For example, the first wall 534 and the second wall 536 may be manufactured separately and assembled prior to or during assembly of the prosthesis assembly 500.

[0036] The first wall 534 can be configured to cover a first wall 540 of the shackle 518. The second wall 536 can be configured to cover a second wall 542 of the shackle 518. The first wall 534 and the second wall 536 can come together on a forward edge 544 of the shackle 518. The first wall 534 and the second wall 536 can include an attachment mechanism 519 that removably couples the first wall 534 to the second wall 536 to form the wall 514. The attachment mechanism 519 can also constrain relative movement in one or more directions between the first wall 534 and the second wall 536. For example, the attachment mechanism 519 can include a dovetail formation that couples the first wall 534 and the second wall 536. In another embodiment, the attachment mechanism 519 can include a tongue and groove that can couple the first wall 534 and the second wall 536. In yet another embodiment, the attachment mechanism 519 can be any attachment mechanism capable of coupling the first wall 534 and the second wall 536 together. For example, the attachment mechanism 519 can include tabs, slots, patterns, protrusions, grooves, or any other geometric features that can be used to couple the first wall 534 and the second wall 536 together.

[0037] In an embodiment, at least a portion of the first wall 534 can include a frustoconical profile 535 and at least a portion of the second wall 536 can include a frustoconical profile 537. The frustoconical profile 535 of the first wall 534 can be complementary to the frustoconical profile 513 of the internal medial condyle wall 509 and the frustoconical profile 537 of the second wall 536 can be complementary to the frustoconical profile 515 of the internal lateral condyle wall 511. For example, during engagement of the prosthesis assembly 500, the frustoconical profile 513 of the internal medial condyle wall 509 can engage with the frustoconical profile 535 of the first wall 534 and the frustoconical profile 515 of the internal lateral condyle wall 511 can engage with the frustoconical profile 537 of the second wall 536. The frustoconical profiles, such as frustoconical profile 513, frustoconical profile 515, frustoconical profile 535 and frustoconical profile 537, can provide additional clearance between the femoral component 506 and the wall 514 while maintaining the strength of the femoral component 506 and the wall 514 compared to a stepped design or any other design that can be used to improve clearance between the femoral component 506 and the shackle 518.

[0038] 8 is a cross-sectional view of a portion of a prosthesis assembly 500, according to one embodiment of the present application, in which the prosthesis assembly 500 is shown in different orientations to illustrate how different components of the prosthesis assembly 500 interact with one another during operation of the prosthesis assembly 500.

[0039] In the orientation 802, the knee joint or prosthesis assembly 500 may be extended such that the bump stop 528 contacts the shackle 518 to prevent further rotation of the femoral component 506 relative to the tibial component, such as the tibial bearing component 504 of FIG. 5. For example, the bump stop 528 may contact the shackle 518 to prevent further rotation (or further extension) of the prosthesis assembly 500. As shown in FIG. 8, the size of the bump stop 528 may determine how much rotation the prosthesis assembly 500 will tolerate. For example, the height or thickness between the surface of the bump stop 528 that faces the femoral component 506 and the bump stop 528 configured to contact the shackle 518 may determine the limit of rotation of the femoral component 506 relative to the tibial bearing component 504 (see FIG. 5). For example, the thickness of the bump stop 528 can be decreased to allow more rotation before the bump stop 528 contacts the shackle 518. The thickness of the bump stop 528 can be increased to allow less rotation of the femoral component 506 relative to the tibial bearing component 504. In another embodiment, the shape of the surface of the bump stop 528 can be altered to change when the bump stop 528 contacts the shackle 518. For example, the bump stop 528 can be flat, rounded, or any other shape that can affect the amount of rotation of the femoral component 506 relative to the tibial bearing component 504.

[0040] In some embodiments, the system may include multiple bump stops 528 to provide multiple angles of rotation of the femoral component 506 relative to the tibial bearing component 504. Here, the system may provide multiple bump stops 528 such that the bump stops 528 may be selected before or during assembly of the prosthetic assembly 500, or after implantation of the prosthetic assembly 500, to adjust the amount of rotation of the femoral component 506 relative to the tibial bearing component 504 before the bump stops 528 contact the shackle 518. For example, a surgeon may implant the prosthetic assembly 500 and determine the appropriate bump stop 528 based on range of motion testing or any other indicator. In another embodiment, the bump stops 528 may be changed while the patient's knee is healing. For example, the bump stop 528 may be initially large to prevent greater rotation of the femoral component 506 relative to the tibial bearing component 504, and as the patient heals, the bump stop 528 can be changed to a smaller sized bump stop 528 to allow more rotation of the femoral component 506 relative to the tibial bearing component 504.

[0041] In the orientation 804, the knee joint and prosthesis assembly 500 can be articulated to rotate the femoral component 506 about the hinge axis 512 to move the bump stop 528 away from the shackle 518. For example, the state of the prosthesis assembly 500 or knee joint where the bump stop 528 is furthest from the axis can be referred to as a flexed state. In the flexed state, the bump stop 528 can be exposed or accessible from the front of the prosthesis assembly 500. In the flexed state, the bump stop 528 can be serviced. For example, the bump stop 528 can be removed or replaced with a different size bump stop. As can be seen in FIG. 8, the bump stop 538 can include a ridge or bulge that can fit within a seat or groove of the femoral component 506 such that the bump stop 538 can be press fit into the femoral component 506 to couple the bump stop 538 with the femoral component 506. Additionally, the bump stop 538 is removable by passing the apex or ridge of the bump stop 538 through a groove in the femoral component 506. In alternative embodiments, any other press-fit or quick release attachment can be used to secure the bump stop 538 within the femoral component 506.

[0042] In another embodiment, the seating of the bump stop 528 within the femoral component 506 can be adjusted to change the amount of rotation of the femoral component 506 relative to the tibial bearing component 504 before the bump stop 528 contacts the shackle 518. For example, the bump stop 528 can include a number of ridges or protrusions that can fit within a groove in the femoral component 506 to adjust the seating of the bump stop 528 and change the clearance between the femoral component 506 and the shackle 518 when the femoral component 506 contacts the shackle 518. Such an adjustment can change the amount of rotation before the bump stop 528 contacts the shackle 518 to alter the amount of rotation of the femoral component 506 relative to the tibial bearing component 504.

[0043] In the embodiment shown in orientation 806, the bump stop 528 of orientations 802 and 804 can be removed and replaced with a bump stop, such as a different size bump stop 528 as shown in orientations 806 and 808. As shown in orientation 806, the bump stop 528 can be replaced with a larger version of the bump stop 528. As discussed above, the larger version of the bump stop 528 can contact the shackle 518 sooner to prevent rotation of the femoral component 506 relative to the tibial bearing component 504. In another embodiment, the size of the bump stop 528 can be reduced to increase the amount of rotation of the femoral component 506 relative to the tibial bearing component 504.

[0044] As shown in orientation 808, the amount of rotation of the femoral component 506 relative to the tibial bearing component 504 can be modified by placing a bump stop, such as the different sized bump stop 528 shown in orientations 806 and 808. As shown in orientation 808, the increased size of the bump stop 528 compared to the bump stop 528 in orientations 802 and 804 can reduce the amount of rotation of the femoral component 506 relative to the tibial bearing component 504.

[0045] The following non-limiting examples detail certain aspects of the subject matter for solving the problems and providing, among other things, the advantages discussed herein. EXAMPLES

[0046] Example 1 is a constrained knee prosthesis assembly including a tibial tray, a tibial bearing component including an articular surface, a hinge post extending through the tibial bearing component and at least partially received within a recess of the tibial tray, a femoral component configured to contact the articular surface of the tibial bearing component and articulate with the tibial bearing component, a shackle coupled to the hinge post at a first end and configured to be inserted between a medial condyle and a lateral condyle of the femoral component, the shackle including a first side and a second side opposite the first side, walls positioned between the femoral component and the shackle and engaged by the femoral component, the walls including a first wall configured to cover the first side of the shackle and a second wall configured to cover the second side of the shackle, the first wall attached to the second wall, and a hinge shaft configured to secure the femoral component to the shackle.

[0047] In Example 2, the subject matter of Example 1 includes a bump stop removably attached to the femoral component, the bump stop configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component.

[0048] In example 3, the subject matter of example 2 includes the bump stop configured to be disengaged when the knee joint is in flexion.

[0049] In Example 4, the subject matter of Examples 2-3 includes a size of the bump stop that determines a set limit of rotation of the femoral component relative to the tibial bearing component.

[0050] In example 5, the subject matter of example 4 includes where the bump stop is configured to be selectively maintainable.

[0051] In Example 6, the subject matter of Examples 1-5 includes wherein the first wall is removably attached to the second wall.

[0052] In Example 7, the subject matter of Example 6 includes the first wall and the second wall being coupled by an engagement mechanism.

[0053] In example 8, the subject matter of example 7 includes where the engagement mechanism includes a dovetail connection between the first wall and the second wall.

[0054] In Example 9, the subject matter of Examples 6-8 includes where the exterior surface of the first wall at least partially comprises a first frustoconical profile.

[0055] In Example 10, the subject matter of Example 9 includes where an exterior surface of the second wall at least partially comprises a second frustoconical profile.

[0056] In example 11, the subject matter of example 10 includes, wherein the medial wall of the medial condyle of the femoral component includes a third frusto-conical profile complementary to the first frusto-conical profile.

[0057] In Example 12, the subject matter of Example 11 includes, wherein the medial wall of the lateral condyle of the femoral component includes a fourth frustoconical profile complementary to the second frustoconical profile.

[0058] Example 13 is a constrained knee prosthesis assembly including a tibial tray, a tibial bearing component including an articular surface, a hinge post extending through the tibial bearing component and at least partially received within a recess in the tibial tray, a femoral component contacting the articular surface of the tibial bearing component, a shackle coupled to the hinge post at a first end and configured to be inserted between a medial condyle and a lateral condyle of the femoral component, a wall positioned between the femoral component and the shackle and engaged by the femoral component, a hinge axis configured to secure the femoral component relative to the shackle, and a bump stop removably attached to the femoral component, the bump stop configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component.

[0059] In example 14, the subject matter of example 13 includes where the bump stop is configured to be selectively removable.

[0060] In Example 15, the subject matter of Examples 13-14 includes a size of the bump stop that determines a set limit of rotation of the femoral component relative to the tibial bearing component before the bump stop contacts the shackle.

[0061] Example 16 is a constrained knee prosthesis assembly, comprising a tibial tray, a tibial bearing component including an articular surface, a hinge post extending through the tibial bearing component and at least partially received within a recess in the tibial tray, and a femoral component in contact with the articular surface of the tibial bearing component, the femoral component including an internal medial condyle wall facing the intercondylar region and including a first frustoconical profile, and an internal lateral condyle wall facing the intercondylar region and including a second frustoconical profile, and a hinge post coupled at a first end to the hinge post and inserted within the intercondylar region. a shackle configured to be attached to the femoral component, the shackle including a first side and a second side opposite the first side; a wall positioned between the femoral component and the shackle to cover the first and second sides of the shackle, the wall including a third frusto-conical profile complementary to the first frusto-conical profile of the internal medial condyle wall and a fourth frusto-conical profile complementary to the second frusto-conical profile of the internal lateral condyle wall; and a hinge axis configured to secure the femoral component to the shackle.

[0062] In Example 17, the subject matter of Example 16 includes a bump stop removably attached to the femoral component, the bump stop configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component.

[0063] In example 18, the subject matter of example 17 includes the bump stop configured to be disengaged when the knee joint is in flexion.

[0064] In Example 19, the subject matter of Examples 17-18 includes a size of the bump stop that determines a set limit of rotation of the femoral component relative to the tibial bearing component when the bump stop contacts the shackle.

[0065] In Example 20, the subject matter of Examples 17-19 includes the bump stop configured to be selectively maintainable.

[0066] Example 21 is an apparatus including means for implementing any of examples 1 to 20.

[0067] Example 22 is a system for implementing any of Examples 1 to 20.

[0068] Example 23 is a method for implementing any of examples 1 to 20.

[0069] The above detailed description includes references to the accompanying drawings, which form a part of this detailed description. The drawings show, by way of illustration, specific embodiments that can be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements in addition to those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are included. Moreover, the inventors also contemplate examples using any combination or permutation of what has been shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0070] All publications, patents, and patent documents referred to herein are incorporated herein in their entirety as if individually incorporated by reference. In the event of a conflict of usage between this specification and these documents, the usage in the incorporated references shall be deemed to supplement that of this specification.

[0071] The terms "a" or "an" are used herein, as is common in patent documents, to include one or more, regardless of any other instance or usage of either "at least one" or "one or more." In this specification, unless otherwise indicated, the term "or" is used to mean a non-exclusive or, or "A or B" is used to include "A but B," "B but not A," and "A and B." In the appended claims, the terms "including" and "in which" are used as the plain English equivalents of the terms "comprising" and "wherein," respectively. Also, in the following claims, the terms "including" and "comprising" are open-ended; that is, a system, device, article, or process that includes elements other than those recited after such terms in a claim is still deemed to be within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third" are used merely as labels and are not intended to impose numerical requirements on their objects.

[0072] The term "about" as used herein means approximately, in the region of, roughly, or around. When the term "about" is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the stated numerical values. In general, the term "about" is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one embodiment, the term "about" means ±10% of the numerical value of the number with which it is used. Thus, about 50% means within a range of 45% to 55%. Numerical ranges described herein by endpoints include all numbers and fractions subsumed within that range, for example 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5. Additionally, numerical ranges recited herein by endpoints include the subranges subsumed within that range, for example, 1 to 5 includes 1 to 1.5, 1.5 to 2, 2 to 2.75, 2.75 to 3, 3 to 3.90, 3.90 to 4, 4 to 4.24, 4.24 to 5, 2 to 5, 3 to 5, 1 to 4, and 2 to 4. It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term "about."

[0073] The foregoing description is intended to be illustrative, not limiting. For example, the above-described embodiments (or one or more aspects thereof) may be used in combination with each other. For example, one of ordinary skill in the art may use other embodiments upon review of the above description. The Abstract is provided to enable the reader to quickly ascertain the contents of the technical disclosure, with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Additionally, in the foregoing detailed description, various features may be grouped together to simplify the disclosure. This should not be construed as intending that any unclaimed feature of the disclosed subject matter is essential to any claim. Rather, inventive subject matter may reside in less than all features of a particular disclosed embodiment. Thus, the following claims are incorporated into this more detailed description, with each claim standing on its own as a separate embodiment. The scope of the embodiments should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. According to aspect (1), there is provided a constrained knee prosthesis assembly, comprising: A tibial tray; a tibial bearing component including an articular surface; a hinge post extending through the tibial bearing component and at least partially received within a recess of the tibial tray; a femoral component configured to contact the articular surface of the tibial bearing component and to articulate with the tibial bearing component; a shackle coupled at a first end to the hinge post and configured to be inserted between a medial condyle and a lateral condyle of the femoral component, A first side portion, and a second side opposite the first side; a shackle including a wall positioned between the femoral component and the shackle and engaged by the femoral component, a first wall configured to cover the first side of the shackle; and a second wall configured to cover the second side of the shackle, the first wall being attached to the second wall; A wall including a hinge axis configured to secure the femoral component to the shackle; A prosthesis assembly comprising: According to aspect (2), the present invention includes a bump stop removably attached to the femoral component, the bump stop being configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component. According to aspect (3), the bump stop is configured to be removed when the knee joint is in a flexed state. According to aspect (4), the size of the bump stop determines the set limit of rotation of the femoral component relative to the tibial bearing component. According to aspect (5), the bump stop is configured to be selectively maintainable. According to aspect (6), the first wall is removably attached to the second wall. According to aspect (7), the first wall and the second wall are coupled by an engagement mechanism. According to aspect (8), the engagement mechanism includes a dovetail connection between the first wall and the second wall. According to aspect (9), an outer surface of the first wall at least partially comprises a first frustoconical profile. According to aspect (10), an outer surface of the second wall at least partially comprises a second frustoconical profile. According to aspect (11), the inner wall of the medial condyle of the femoral component includes a third frustoconical profile complementary to the first frustoconical profile. According to aspect (12), the inner wall of the lateral condyle of the femoral component includes a fourth frustoconical profile complementary to the second frustoconical profile. According to an aspect (13), there is provided a constrained knee prosthesis assembly, comprising: A tibial tray; a tibial bearing component including an articular surface; a hinge post extending through the tibial bearing component and at least partially received within a recess of the tibial tray; a femoral component in contact with the articular surface of the tibial bearing component; a shackle coupled at a first end to the hinge post and configured to be inserted between the medial and lateral condyles of the femoral component; a wall positioned between the femoral component and the shackle and engaged by the femoral component; a hinge axis configured to secure the femoral component to the shackle; a bump stop removably attached to the femoral component, the bump stop configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component; A prosthesis assembly comprising: According to aspect (14), the bump stop is configured to be selectively removable. According to aspect (15), the size of a bump stop determines a set limit of rotation of the femoral component relative to the tibial bearing component before the bump stop contacts the shackle. According to an aspect (16), there is provided a constrained knee prosthesis assembly, comprising: A tibial tray; a tibial bearing component including an articular surface; a hinge post extending through the tibial bearing component and at least partially received within a recess of the tibial tray; a femoral component in contact with the articular surface of the tibial bearing component, an internal medial condyle wall facing the intercondylar region and including a first frustoconical profile; and an inner lateral condyle wall facing the intercondylar region and including a second frustoconical profile; a femoral component including: a shackle coupled at a first end to the hinge post and configured to be inserted into the intercondylar region, A first side portion, and a second side opposite the first side; a shackle including a wall positioned between the femoral component and the shackle to cover the first side and the second side of the shackle, a third frustoconical profile complementary to the first frustoconical profile of the internal medial condyle wall; and a fourth frustoconical profile complementary to the second frustoconical profile of the inner lateral condyle wall; A wall including a hinge axis configured to secure the femoral component to the shackle; A prosthesis assembly comprising: According to aspect (17), the present invention includes a bump stop removably attached to the femoral component, the bump stop configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component. According to aspect (18), the bump stop is configured to be removed when the knee joint is in flexion. According to aspect (19), the size of a bump stop determines a set limit of rotation of the femoral component relative to the tibial bearing component when the bump stop contacts the shackle. According to aspect (20), the bump stop is configured to be selectively maintainable.

Claims

1. 1. A constrained knee prosthesis assembly comprising: A tibial tray; a tibial bearing component including an articular surface; a hinge post extending through the tibial bearing component and at least partially received within a recess of the tibial tray; a femoral component configured to contact the articular surface of the tibial bearing component and to articulate with the tibial bearing component; a shackle coupled at a first end to the hinge post and configured to be inserted between a medial condyle and a lateral condyle of the femoral component, A first side, and a second side opposite the first side; a shackle including a wall positioned between the femoral component and the shackle and engaged by the femoral component, a first wall configured to cover the first side of the shackle; and a second wall configured to cover the second side of the shackle, the first wall being attached to the second wall; A wall including a hinge axis configured to secure the femoral component to the shackle; Including, the first wall is removably attached to the second wall; an exterior surface of the first wall at least partially comprises a first frustoconical profile; Prosthesis assembly.

2. 2. The prosthesis assembly of claim 1, including a bump stop removably attached to the femoral component, the bump stop configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component.

3. The prosthesis assembly of claim 2 , wherein the bump stop is configured to be removed when the knee joint is in flexion.

4. The prosthesis assembly of claim 2 , wherein a size of a bump stop determines a set limit of rotation of the femoral component relative to the tibial bearing component.

5. The prosthesis assembly of claim 4 , wherein the bump stop is configured to be selectively maintainable.

6. The prosthesis assembly of claim 1 , wherein the first wall and the second wall are coupled by an engagement mechanism.

7. The prosthesis assembly of claim 6 , wherein the engagement mechanism includes a dovetail connection between the first wall and the second wall.

8. The prosthesis assembly of claim 1 , wherein an outer surface of the second wall at least partially comprises a second frustoconical profile.

9. The prosthesis assembly of claim 8 , wherein an inner wall of the medial condyle of the femoral component includes a third frustoconical profile complementary to the first frustoconical profile.

10. The prosthesis assembly of claim 9 , wherein an inner wall of the lateral condyle of the femoral component includes a fourth frustoconical profile complementary to the second frustoconical profile.

11. A bump stop removably attached to the femoral component, the bump stop configured to contact the shackle at a set limit of rotation of the femoral component relative to the tibial bearing component; The prosthesis assembly of claim 1 , comprising:

12. The prosthesis assembly of claim 11 , wherein the bump stop is configured to be selectively removed.

13. The prosthesis assembly as described in claim 11, wherein the set limit of rotation of the femoral component relative to the tibial bearing component is changed by changing the size of the bump stop.

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